Total dose of propofol administered to each patient [ Time Frame: After each sedation ] [ Designated as safety issue: No ]

Analyzed using descriptive statistics and mixed model regression methods. Raw mean total dose administered and raw percentage of times additional propofol was administered will be presented by sedation group treating each event (sedation with lumbar puncture) as the unit. T-test and chi-square tests will be performed as appropriate.

Original Primary Outcome Measures ICMJE (submitted: January 20, 2012)

Total dose of propofol administered to each patient [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

To determine whether the application of a topical anesthetic (EMLA cream) to the LP site will decrease the total dose of propofol administered to pediatric oncology patients who are being sedated for LPs compared to application of a topical placebo cream.

Level of movement (no movement, minor movement, major movement, other) after EMLA cream or placebo cream administration [ Time Frame: At the time of LP insertion ] [ Designated as safety issue: No ]

Complications including any change in vital signs that requires intervention by the sedation team, as well as post-LP headache and post-LP back pain from sedation with or without EMLA cream [ Time Frame: Within one week of the LP ] [ Designated as safety issue: No ]

A Randomized, Double Blind Trial of Pediatric Lumbar Puncture Under Sedation/Total Intravenous Anesthesia (TIVA) With and Without EMLA Cream

Brief Summary

This randomized clinical trial studies local anesthetic (EMLA) cream in younger patients undergoing lumbar punctures (LP). A local anesthetic cream may be effective for numbing the skin and reducing movement when applied prior to lumbar punctures and may reduce the amount of sedation necessary

Detailed Description

PRIMARY OBJECTIVES:

I. To determine whether the application of a topical anesthetic (EMLA cream) to the LP site will decrease the total dose of propofol administered to pediatric oncology patients who are being sedated for LPs compared to application of a topical placebo cream.

SECONDARY OBJECTIVES:

I. To determine whether the use of EMLA cream decreases complication rates from sedation.

II. To determine whether the use of EMLA cream decreases traumatic lumbar punctures.

III. To determine whether the use of EMLA cream shortens recovery time. IV. To determine practitioner and parent satisfaction with the use of EMLA cream.

Patients receive topical EMLA cream 60 minutes to 4 hours prior to the LP followed by standard sedation with fentanyl citrate and propofol.

Interventions:

Drug: EMLA

Drug: propofol

Drug: fentanyl citrate

Active Comparator: Arm II (placebo)

Patients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation with fentanyl citrate and propofol.

Interventions:

Drug: placebo administration

Drug: propofol

Drug: fentanyl citrate

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Recruiting

Estimated Enrollment ICMJE

40

Completion Date

Not Provided

Estimated Primary Completion Date

July 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

Pediatric oncology patients undergoing a lumbar puncture in the Pediatric Sedation Suite; patients may or may not be receiving intrathecal chemotherapy

Exclusion Criteria:

Patients undergoing additional procedures during the same anesthetic such as bone marrow aspirate or biopsy will be excluded because they will likely require higher doses of propofol than those undergoing LP alone Patients who are allergic to or not tolerant of EMLA cream, propofol, or fentanyl will be excluded Patients who are pregnant will be excluded Patients having their LPs done by students will be excluded